1、BSI Standards PublicationBS EN ISO 5361:2012Anaesthetic and respiratory equipment Tracheal tubes and connectors (ISO 5361:2012)Incorporating corrigendum December 2012BS EN ISO 5361:2012National forewordThis British Standard is the UK implementation of EN ISO 5361:2012, incorporating corrigendum Dece
2、mber 2012. It supersedes BS EN 1782:1998+A1:2009 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/121, Anaesthetic and respiratory equipment to Subcommittee CH/121/5, Lung ventilators, tracheal tubes and related equipment.A list of organizations repr
3、esented on this subcommittee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2014. Published by BSI Standards Limited 2014ISBN 978
4、 0 580 81661 1ICS 11.040.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2012.Amendments/corrigenda issued since publicationDate Text affected30 Apri
5、l 2014 Implementation of CEN corrigendum December 2012: supersession details updatedBRITISH STANDARDEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 5361 October 2012 ICS 11.040.10 English Version Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2012) Matriel d
6、anesthsie et de ranimation respiratoire - Sondes trachales et raccords (ISO 5361:2012) Ansthesie- und Beatmungsgerte - Trachealtuben und Verbindungsstcke (ISO 5361:2012) This European Standard was approved by CEN on 15 September 2012. CEN members are bound to comply with the CEN/CENELEC Internal Reg
7、ulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN mem
8、ber. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
9、CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland
10、, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form an
11、d by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 5361:2012: EIncorporating corrigendum December 2012BS EN ISO 5361:2012EN ISO 5361:2012 (E) 3 Foreword This document (EN ISO 5361:2012) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipmen
12、t“ in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2013,
13、 and conflicting national standards shall be withdrawn at the latest by October 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights.
14、This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. According to
15、 the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece
16、, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 5361:2012 has been approved by CEN as a EN ISO 5361:2012 without
17、 any modification. EN ISO 5361:2012 supersedes EN 1782:1998+A1:2009.BS EN ISO 5361:2012EN ISO 5361:2012 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to
18、CEN by the European Commission and the European Free Trade Association to provide a means to conforming to Essential Requirements of Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a na
19、tional standard in at least one Member State, compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive. NOTE When an Essential Requi
20、rement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZA 1 Correspondence between this European Standard and Directive 93/42/EEC Clause(s)/sub-clause(s) of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks
21、/notes 5.3 4.1.6 7.1 (2nd indent) 7.1 (3rd indent) In the EU, competent authorities always require applicable ERs. 5.3.1 7.1 7.2 7.2 7.1 and 7.2 covers the integrity of the packaging only for devices supplied sterile. 4.1.1 4.1.2 5.3 7.3 4.1.1, 4.1.2, and 5.3 mandates a risk assessment be carried ou
22、t which does not exclude risks associated with materials and the substances with which they may come into contact. Does not cover devices intended to administer medicinal products. 5.3.4 8.3.1 m) 7.5 Partly addressed by 5.3.4 and 8.3.1 m), calls specifically for a warning if phthalates are incorpora
23、ted. However, justification for the use of phthalates for use with children or pregnant or nursing women is not covered. 7.2 8.1 7.2 mandates the requirements of ISO 11607-1 to ensure that the packaging is suitable to prevent contamination during transportation and use. 7.2 8.3 Partly addressed by 7
24、.2 which mandates the requirements of ISO 11607-1 that the packaging is suitable to prevent contamination during transportation and use. 7.1 8.4 7.1 mandates that sterile devices satisfy 4.1 of EN 556-1. BS EN ISO 5361:2012EN ISO 5361:2012 (E) 5 Clause(s)/sub-clause(s) of this European Standard Esse
25、ntial Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/notes 7.1 8.5 7.1 mandates that sterile devices satisfy 4.1 of EN 556-1. 8.3.1 h) 8.7 Partly covered. Marked sterile if appropriate. 5.2.2 5.5.4, 5.9, 5.5.1 9.1 Generally covered by mandating construction and testing of the interface
26、 connector, resistance to tube collapse and kinking, and cuff leakage. 5.1 5.2 Tables 1a), 1b), and 1c) 5.5 5.7 6 8.3.2 b) 9.2 (first and second indent) Partly covered to address only the risk of injury in connection with their physical features by specifying sizing and marking conventions for the I
27、D/OD of the tracheal tube, curvature of the tube, marking for the OD of the cuff, and pressure limits for cuff performance testing. 8.2.1.1 d), e), and f) 10.1 (first sentence) Partly covered to address length measurement and marking in cm. Limits of accuracy are specified in the standard and not di
28、sclosed by the manufacturer. 8.2.1.1 d), e), and f) 10.2 Length marking positions are mandated to provide ergonomic angular visibility during intubation. 8.2.1.1 d), e), and f) 10.3 Length marking is mandated using SI units (cm). 5.2.2.5 5.6.5 12.7.4 Tracheal tube gas connectors are mandated to comp
29、ly with ISO 5356-1 for 15 mm connectors. Tracheal tube cuff inflation connectors are mandated to comply with ISO 594-1 for Luers. 8 4.2.1 NOTE 13.1 Covered by mandating marking and labelling and instructions on the tube, connector, unit label, and instructions for use. 4.2.1 Safety note draws attent
30、ion to consideration of disclosure of specific labelling and instructions for intended use that may deviate from the currently accepted medical practice. 8.1 13.2 Symbols are mandated in 8.1 to conform to EN 1041 and ISO 7000 or EN 980 or ISO 15223-1 and ISO 15223-2. 8.2.1.1 a) 8.3.1 f) 13.3 a) Manu
31、facturer identification mandated on the device and on individual pack or any insert. Authorised representative mandated on the individual pack or any insert. 7.2 8.3.1 h) 13.3 b) Only identifies that the device is sterile (if applicable). 8.3.1 h) 13.3 c) BS EN ISO 5361:2012EN ISO 5361:2012 (E) 6 Cl
32、ause(s)/sub-clause(s) of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/notes 8.3.1 g) 13.3 d) Batch code preceded by the word “LOT” mandated for EU countries. 8.3.1 g) 13.3 e) Use by date is only addressed via a strong recommendation; The EU regulation
33、 makes it mandatory. 8.3.1 i) 13.3 f) 4.2.1 NOTE 13.3 j) 4.2.1 Safety note draws attention to consideration of disclosure of specific labelling and instructions for intended use that may deviate from the currently accepted medical practice. This NOTE is mandatory to cover this ER. 8.3.1 h) NOTE 13.3
34、 m) This NOTE is mandatory to cover this ER. 8.4 13.5 Limited to detachable connectors, which are marked with the designated tracheal tube size. 8 13.6, a), b), c) Mandated markings, labelling and instructions. 8.3.1 l) 13.6 h), first and second paragraphs Mandated instructions for cleaning and disi
35、nfection or sterilization. Risks associated with the reuse of devices marked for single use are covered partly by the risk management file and use of the informative Annex F Hazard identification for risk assessment 8.3.2 a) 13.6 i) Details for preparation for use are mandated for disclosure. 8.3.2
36、c) 13.6 q) The date of issue of the latest revision of instructions for use is mandated. WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 5361:2012ISO 5361:2012(E) ISO 2012 All rights reserved iiiContents Pag
37、eForeword ivIntroduction v1 *Scope 12 Normative references . 13 Terms and definitions . 24 *General requirements for tracheal tubes and tracheal tube connectors . 54.1 Risk assessment . 54.2 Safety 65 Specific requirements for tracheal tubes and tracheal tube connectors . 65.1 Size designation 65.2
38、Dimensions . 65.3 *Materials .145.4 Tracheal tube bevel .155.5 *Tracheal tube cuffs 155.6 Inflating system for cuffs 165.7 Curvature of the tube .165.8 *Radiopaque marker .185.9 *Kink resistance .186 Additional requirement for tracheal tubes with a Murphy eye 196.1 Size of the Murphy eye .196.2 Loca
39、tion of the Murphy eye 196.3 Resistance to kinking or collapse of the Murphy eye .196.4 Surface characteristics of the Murphy eye .197 Requirements for tracheal tubes with tracheal tube connectors supplied sterile 207.1 Sterility assurance 207.2 Packaging for tracheal tubes and tracheal tube connect
40、ors supplied sterile 208 Marking .208.1 Use of symbols 208.2 Tracheal tubes 208.3 Marking on the tracheal tube individual pack or any insert 218.4 Marking on tracheal tube connectors 23Annex A (informative) Rationale .24Annex B (normative) Determination of cuff diameter .28Annex C (normative) Test m
41、ethod for cuffed tube collapse .29Annex D (normative) *Test method for cuff herniation.32Annex E (informative) Guidance on design of tracheal tube connectors .34Annex F (informative) Hazard identification for risk assessment .35Annex G (normative) *Test method for tracheal seal 38Annex H (normative)
42、 Test method to determine kink resistance 41Bibliography .43BS EN ISO 5361:2012ISO 5361:2012(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carrie
43、d out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. IS
44、O collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare Internationa
45、l Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.Attention is drawn to the possibility that some of the elemen
46、ts of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.This second edition cancels and replaces the first edition (ISO 5361:1999), which has been technically revised.The requirements of ISO 5361-4, Tracheal tubes Part
47、4: Cole type, have been included in this second edition because Cole type tracheal tubes are specialized tubes, and as such, are now included in the scope of this International Standard.Throughout this Particular Standard, terms defined in Clause 3 or in ISO 4135 appear in bold type.Throughout this
48、Particular Standard, text for which a rationale is provided in Annex A is indicated by an asterisk (*).iv ISO 2012 All rights reservedBS EN ISO 5361:2012ISO 5361:2012(E)IntroductionThis International Standard provides the essential performance and safety requirements for the design of tracheal tubes
49、 and tracheal tube connectors. Tracheal tubes are intended to be inserted through the larynx into the trachea to convey gases and vapours to and from the trachea.Tracheal tubes with cuffs are intended to seal and protect the trachea from aspiration of secretions and to provide an unobstructed airway in patients during spontaneous, assisted, or controlled ventilation for short or prolonged durations.A variety of cuff designs are available to meet particular clinical requirements. Cuff performance requirements with associated test methods have been added to th
